Focal salvage brachytherapy for recurrent prostate cancer
Official title: Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
Run by The Greater Poland Cancer Centre · NCT05715502 · Data updated 2026-11-12
This study is testing a targeted radiation treatment for men with recurring prostate cancer after previous radiation to see if it can help them without harming nearby organs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 100 (estimated) |
| Sponsor | The Greater Poland Cancer Centre Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Poznan, Greater Poland Voivodeship) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2028 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT05715502 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men with histologically confirmed localized recurrence of prostate cancer after prior radical radiotherapy and specific PSA levels.
✕Probably not a fit
Patients with distant metastases, high PSA levels, or significant comorbidities may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective phase II study evaluates the safety and toxicity of focal salvage brachytherapy in patients with localized recurrence of prostate cancer after prior radiotherapy. The study aims to treat patients who have experienced local recurrence while ensuring that critical organs are protected from excessive radiation exposure. Patients will undergo imaging assessments to confirm localized tumors and exclude distant metastases before receiving the brachytherapy treatment. The goal is to provide a targeted approach that may improve outcomes for patients with recurrent prostate cancer.
Why it matters
Potential benefit: If successful, this treatment could offer a less toxic and more effective option for patients with recurrent prostate cancer.
How similar studies have gone: Previous studies have shown promise for salvage brachytherapy in similar patient populations, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy) * Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT * Exclusion of distant metastases using CT, MR, or PET imaging * PSA doubling time over six months * PSA value \<10 ng / ml * No anti-androgen treatment in the year prior * Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points * General condition according to the WHO scale ≤ 2 * Signing informed consent to participate in the study Exclusion Criteria: * PSA value\> 10ng / ml * General condition according to the WHO scale\> 2 * Dysuria on the IPSS scale\> 20 points * PSA doubling time \<6 months * Inability to discontinue anticoagulants. * An active urinary tract infection. * Contraindications to general anesthesia * Active inflammatory bowel diseases. * Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer * Estimated Survival \<5 years
Where it's running
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Greater Poland Cancer Centre / Brachytherapy Department
Poznan, Greater Poland Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Wojciech Burchardt, PhD, MD — Greater Poland Cancer Centre / Brachytherapy Department
- Study coordinator: Wojciech Burchardt, PhD, MD
- Email: wojciech.burchardt@wco.pl
- Phone: +48505149659
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.